Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, overweight, insulin, liraglutide
Brief summary
To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population. Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
Detailed description
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.
Interventions
DRUGLiraglutide
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
DRUGPlacebos
placebo will be compared to liraglutide for 24 weeks in a cross-over design
Sponsors
Novo Nordisk A/S
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years
Exclusion criteria
* diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Changes in Glycemic Control by HbA1c. | Measure changes in HbA1c at 24 and 52 weeks from baseline | To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Changes on Adipose Tissue | Measure changes in the composite at 24 and 52 weeks from baseline | To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Patients beginning with liraglutide will be switched to Placebo and vice versa | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Region of Enrollment Canada | 15 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Assessment of Changes in Glycemic Control by HbA1c.
To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.
Time frame: Measure changes in HbA1c at 24 and 52 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Assessment of Changes in Glycemic Control by HbA1c. | 0.3 percentage of HbA1c | Standard Deviation 0.1 |
| Placebo | Assessment of Changes in Glycemic Control by HbA1c. | 0.2 percentage of HbA1c | Standard Deviation 0.1 |
Secondary
Assessment of Changes on Adipose Tissue
To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue
Time frame: Measure changes in the composite at 24 and 52 weeks from baseline